BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS, SMARTSITE

    MDR report key: 19719274 · Received July 11, 2024

    Report

    Report Number
    19719274
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    March 28, 2024
    Report Date
    April 17, 2024
    Manufacturer
    BD SWITZERLAND SÀRL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN PUTTING A THREE PORT INFUSION TUBING INTO THE PUMP, THE TUBING SNAPPED OPEN BY THE BLUE CONNECTOR THAT GOES INTO THE TOP OF THE PUMP CHANNEL. MANUFACTURER RESPONSE FOR SET, ADMINISTRATION, INTRAVASCULAR, ALARIS, SMARTSITE (PER SITE REPORTER). WAITING FOR A RESPONSE FROM THE VENDOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314458 ALARIS, SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR FPA BD SWITZERLAND SÀRL 2426-0007 (10) 23119287

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown